Arbitration Between Habitual and Goal-directed Behavior in Obsessive-compulsive Disorder: Circuit Dynamics and Effects of Noninvasive Neurostimulation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Investigators will recruit 30 male and female adults (age 18-65) with OCD and 30 age-, sex-, and education-matched healthy (medically, neurologically and psychiatrically) controls for this project. Each participant will come for three sessions. There will be 3-4 days interval between sessions:
Session 1 that includes initial clinical assessment and obtaining T1 structural image (needed for neuronavigation analysis and electric field modeling).
Session 2 and 3 that include performing two separate decision-making and symptom provocation-avoidance tasks by participants with OCD and healthy controls under two conditions: while scanned inside the MRI scanner (no tDCS) or while receiving neuronavigated tDCS neurostimulation outside the scanner (no fMRI imaging). As participates will perform each task twice, there might be an order effect on task performance. For minimizing the impact of such a potential order effect on imaging and tDCS results, participants will be randomly assigned to undergo scanning in the session 2 and then receive tDCS in the session 3 or in the opposite order (tDCS in session 2 and then imaging in session 3) but in each session only one of imaging or tDCS experiments (for both tasks) will be conducted for each participant. OCD-relevant and aversive picture rating (explained below) will be done always in the session 3 as the last experiment.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Reza Tadayon-Nejad, MD, PhD
- Phone Number: 3102066389
- Email: rtadayonnejad@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
A) OCD participants inclusion criteria:
- DSM-5 diagnostic criteria for OCD as primary (most severe) diagnosis (based on the Mini International Neuropsychiatric Interview).
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score is equal or greater than 16.
- unmediated or being on a stable dose of medication (only SSRIs and clomipramine) for at least 12 weeks prior to the study.
- fluent English speaker.
- signed informed consent.
B) OCD participants exclusion criteria:
- IQ greater than 80 on the Wechsler Abbreviated Scales of Intelligence.
- lifetime DSM-5 diagnosis of mania, psychotic disorder, or substance dependence (per MINI).
- current DSM-5 diagnosis of MDD if Montgomery-Asberg Depression Scale (MADRS) scores are equal or greater than 35 (severe), or ADHD.
- taking any psychotropic medication other than SSRIs or clomipramine.
- severe psychiatric symptom that requires immediate inpatient psychiatric intervention such as suicidality.
- presence of any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment.
C) Healthy control inclusion criteria:
1-males and females age 18-65 years with signed informed consent and IQ greater than 80 on WASI.
D) Exclusion criteria for all participants:
- presence of any MR scan contraindications particularly body metal or positive pregnancy test.
- medical conditions in which cerebral metabolism might be compromised such as thyroid disorders, diabetes or current tobacco smoking (potential effect on imaging endpoints).
- any history of seizure disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Healthy subjects
|
tDCS is a non-invasive brain stimulation method by which constant low direct current can be delivered to the sculpt for changing the excitability of neuronal structure adjunct to the stimulating electrode.
|
|
Active Comparator: OCD subjects
|
tDCS is a non-invasive brain stimulation method by which constant low direct current can be delivered to the sculpt for changing the excitability of neuronal structure adjunct to the stimulating electrode.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength of Behaving Model-based (Goal-directed)
Time Frame: On the second or third session when subjects performed the task in the MRI scanner.
|
Strength of behaving model-based (goal-directed) is measured and quantifiedas a continuous real number between 0 and 1.
Here, having a strength's valueof 1 of behaving model-based means that subject in her/his decision-making,exclusively and always utilizes a model-based (goal-directed) strategy fordecision making and having a value of Zero means not utilizing model-based(goal-directed) strategy at all when decising.
|
On the second or third session when subjects performed the task in the MRI scanner.
|
|
Reaction Time in Response to Stimuli With OCD Themes
Time Frame: On the second or third session when subjects performed the task in the MRI scanner.
|
This is a time interval (in seconds) between the start of presentation of visual stimuli with OCD themes and when subjects pushed a bottom to stop the presentation when they could not tolerate those more during symptom provocation and avoidance task.
|
On the second or third session when subjects performed the task in the MRI scanner.
|
|
Strength of Frontal Arbitration Modulation of Basal Ganglia Habit Region.
Time Frame: On the second or third session when subjects performed the task in the MRI scanner
|
Here, by applying Dynamic Causal Modeling (DCM) method, we measured thestrength of frontal arbitration (the interior frontal gyrus (IFG)) modulation ofbasal ganglia habit region (the posterolateral putamen) in terms of the effective(directed) connectivity between the interior frontal gyrus (IFG) andposterolateral putamen.
This DCM-based effective connectivity can have avalue between -1 and +1.
A value of -1 means a maximum effective connectivitybetween the interior frontal gyrus (IFG) and posterolateral putamen.
A value of+1 means maximum excitatory effective connectivity between the interior frontalgyrus (IFG) and posterolateral putamen.
And a value of 0 means no effectiveconnectivity between the interior frontal gyrus (IFG) and posterolateralputamen.
|
On the second or third session when subjects performed the task in the MRI scanner
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Anxiety Disorders
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
Other Study ID Numbers
- 17-001360
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on OCD
-
NCT05359562Recruiting
-
NCT06731426Recruiting
Clinical Trials on transcranial Direct Current Stimulation (tDCS)
-
NCT02747758TerminatedNeuralgia | Neuropathic Pain
-
NCT03485131CompletedSchizophrenia | Auditory Hallucination
-
NCT05354232RecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder
-
NCT06455527Recruiting
-
NCT05958381RecruitingMultiple Sclerosis, Relapsing-Remitting
-
NCT03844607Active, not recruitingTraumatic Brain Injury | Impulsivity
-
NCT04697901CompletedTranscranial Direct Current Stimulation